safety and pharmacokinetics of dmuc5754a administered intravenously to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer

Conditions: Ovarian Cancer, Pancreatic Cancer

Summary: this is a phase i, multi-center, open-label, dose-escalation study of dmuc5754a administered as a single agent by intravenous (iv) infusion to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer.


Eligibility criteria:
inclusion criteria: * life expectancy of at least 12 weeks * documented willingness to use an effective means of contraception for women of childbearing potential * measurable disease with at least one lesion that can be accurately measured in at least one dimension inclusion criteria specific to patients with ovarian cancer: * advanced, epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months of the most recent treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists * for patients in the dose-expansion cohort of the study only, no more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer inclusion criteria specific to patients with pancreatic cancer: * incurable, locally advanced, or metastatic disease for which no standard therapy exists, consisting of unresectable pancreatic ductal adenocarcinoma, including recurrence of previously-resected disease that is considered unresectable with curative intent * no more than one chemotherapy regimen (approved or experimental) administered in the metastatic setting exclusion criteria: * anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to day 1 * palliative radiation to bone metastases within 2 weeks prior to day 1 * major surgical procedure within 4 weeks prior to day 1 * known active bacterial, viral, fungal, mycobacterial, or other infection (including hiv and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * current grade \>1 toxicity (except alopecia and anorexia) from prior therapy or grade \>1 neuropathy from any cause * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * untreated or active central nervous system (cns) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). patients with a history of treated cns metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the cns, radiographic demonstration of improvement upon the completion of cns-directed therapy and no evidence of interim progression between the completion of cns-directed therapy and the screening radiographic study, and the screening cns radiographic study is \>= 8 weeks since completion of radiotherapy and \>= 4 weeks since the discontinuation of corticosteroids and anticonvulsants. * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease (including stroke, new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmias, and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture * pregnancy or breast-feeding